Incidence Of Adverse Clinical Outcomes Research Articles

Clinical Presentation and Outcomes of Phaeochromocytomas/Paragangliomas in Neurofibromatosis Type 1.

Introduction: Patients with neurofibromatosis type 1 (NF1) are at risk of developing phaeochromocytomas/paragangliomas (PHAEO/PG). Unlike in other familial PHAEO/PG syndromes, there are no published guidelines regarding screening in asymptomatic or normotensive patients with NF1. This strategy may be associated with preventable morbidities in those patients who ultimately present with symptomatic PHAEO/PG. Objective: To describe the mode of presentation and the incidence of adverse clinical outcomes attributed to PHAEO/PG in NF1. Methods: A retrospective study was performed in a tertiary referral centre in collaboration with a national complex NF1 centre. Hospital records and databases between 1998–2018 were searched. Results: Twenty-seven patients with NF1 and PHAEO/PG were identified. In all but one, PHAEO/PG was diagnosed after NF1. The median age at the time of diagnosis of PHAEO/PG was 43 years (range 22–65) and 21/27 (78%) were females. The diagnosis was mostly incidental in 13/27 (48%) while classical PHAEO/PG symptoms were found in 15/27 (56%), and hypertension was found in 14/27 (52%) of NF1 patients prior to PHAEO/PG diagnosis. No patient had undergone biochemical screening for PHAEO/PG. Metastatic disease was evident in 2/27 patients, 8 suffered potentially avoidable complications attributed to PHAEO/PG (including two deaths). Conclusion: The course of PHAEO/PG in NF1 is associated with an unpredictable presentation and potentially avoidable adverse outcomes. We recommend that routine biochemical screening for PHAEO/PG should be part of the care package offered to all patients with NF1 by regular measurements of plasma free or urinary fractionated metanephrines starting from early adolescence and repeated every 3 years.

The impact of age on the innate immune response and outcomes after severe sepsis/septic shock in trauma and surgical intensive care unit patients.

Advancing age is a strong risk factor for adverse outcomes across multiple disease processes. However, septic surgical and trauma patients are unique in that they incur two or more inflammatory insults. The effects of advanced age on sepsis pathophysiology and outcomes remain unclear. We performed a single-center, prospective observational cohort study of surgical intensive care unit patients with severe sepsis/septic shock. Peripheral blood was collected for genomic, cytokine, and biomarker analysis at 0.5 day, 1 day, 4 days, 7 days, 14 days, 21 days, and 28 days after sepsis onset. Based on sensitivity analysis, cohorts were defined as "young" (<55 years) and "aged" (≥55 years). We compared age-defined cohorts to determine differences in patient characteristics, biomarker profiles, and clinical outcomes. The cohort included 173 patients with severe sepsis (n = 93; 53.8%) or septic shock (n = 80; 46.2%), with a mean age of 60.9 (±14.5) years. Intra-abdominal sepsis was the leading source (n = 81; 46.8%), followed by necrotizing soft tissue infection (n = 33, 19.1%) and pneumonia (n = 30; 17.3%). Aged patients had a higher comorbidity burden, but were otherwise similar to the young cohort. The aged cohort had a higher severity of early physiologic derangement (median APACHE II, 23 vs. 18; p = 0.002), greater incidence of multiple organ failure (64.3% vs. 40.4%, p = 0.006), and hospital mortality (15.9% vs. 2.1%; p = 0.016). Six-month mortality was significantly higher in the aged cohort as compared with young cohort (31% vs. 9%; p = 0.003). Aged septic patients biomarker trajectories suggestive of persistent immunosuppression (absolute lymphocyte count, soluble programed death ligand-1) and catabolism (Urine 3MH-Cr ratio, insulin growth factor, IGF1BP3, albumin) out to 28 days after sepsis. Aged, critically ill surgical patients have greater organ dysfunction and incidence of adverse clinical outcomes after sepsis. Biomarker profiles suggest an immunophenotype of persistent immunosuppression and catabolism. Advanced age may necessitate novel therapeutic strategies to promote multisystem organ recovery and improve survival after sepsis. Prognostic, level II.

Intracoronary infusion of alprostadil and nitroglycerin with targeted perfusion microcatheter in STEMI patients with coronary slow flow phenomenon

BackgroundThe treating aims of ST-segment elevation myocardial infarction (STEMI) are vessels recanalization and coronary flow restoration. Coronary slow flow phenomenon (CSFP) is one of the common complications in STEMI patients after percutaneous coronary intervention (PCI) and leads to a higher incidence of adverse clinical outcomes. Alprostadil is a kind of liposomal prostaglandin E1 with beneficial effects on vasodilation, platelet disaggregation and fibrinolysis. But it still remains unclear that whether alprostadil can improve the coronary perfusion in STEMI patients with CSFP after PCI. MethodsIn this study, a total of 57 STEMI cases with CSFP were included, 28 of which received 2 μg alprostadil by intracoronary infusion with targeted perfusion microcatheter while the others received 200 μg nitroglycerin. Coronary angiograms were analyzed by two experienced interventional cardiologists who were blinded to the medicine administration. ResultsWe found that compared with nitroglycerin, alprostadil treatment was significantly more effective in increasing the incidence of TFG 3(78.6% vs. 48.3%, P = 0.021), MBG 3(46.4% vs. 20.7%, P = 0.039), TMPG 3(53.6% vs. 24.1%, P = 0.022) and complete STR (42.8% vs. 17.2%, P = 0.035) and reducing cTFC (28.71 frames vs. 46.03 frames, P = 0.001). Furthermore, in this study, intracoronary infusion of alprostadil with targeted perfusion microcatheter hardly affected the blood pressure and heart rate of patients, and no threaten complication were observed. ConclusionsAlprostadil can effectively alleviate CSFP, which is at the same time secure even for STEMI patients. Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT03296670

Use of the malnutrition screening tool by non-dietitians to identify at-risk patients in a rehabilitation setting: A validation study.

Malnutrition is highly prevalent in rehabilitation patients, and screening is important to allow for timely intervention to reduce the incidence of adverse clinical outcomes. We aimed to determine the reliability and validity of the commonly employed malnutrition screening tool by non-dietitian staff in categorising patients at risk of malnutrition in the rehabilitation setting. This prospective observational cohort study recruited 100 participants on admission to a rehabilitation ward. The malnutrition screening tool was applied by nursing staff and repeated by nutrition assistants. Results were compared to malnutrition as determined by dietitian-applied subjective global assessment of each patient. Inter-rater reliability tests were conducted with two dietitians, two nutrition assistants and two nurses independently but simultaneously recording malnutrition screening tool scores on a subgroup of 15 participants. Agreement between dietitian-determined malnutrition and risk as identified by nutrition assistant and nursing staff screening tool application was only modest (64% and 51%, respectively). While both professions met the a priori criteria for acceptable specificity (≥60%), neither met the criterion for adequate sensitivity (≥80%). The inter-rater reliability of the tool was excellent, with almost perfect agreement (≥0.89) between ward dietitian and nutrition assistants, and moderate to substantial agreement (0.56-0.65) with nursing staff, when compared to a senior dietitian. Non-dietitian staff failed to apply the malnutrition screening tool with sufficient sensitivity in normal ward practice to warrant its use in the rehabilitation setting. Alternative options for identification of malnutrition need to be considered to ensure appropriate treatment.

A Quantitative, Risk-Based Approach to the Management of Neonatal Early-Onset Sepsis

Current algorithms for management of neonatal early-onset sepsis (EOS) result in medical intervention for large numbers of uninfected infants. We developed multivariable prediction models for estimating the risk of EOS among late preterm and term infants based on objective data available at birth and the newborn's clinical status. To examine the effect of neonatal EOS risk prediction models on sepsis evaluations and antibiotic use and assess their safety in a large integrated health care system. The study cohort includes 204 485 infants born at 35 weeks' gestation or later at a Kaiser Permanente Northern California hospital from January 1, 2010, through December 31, 2015. The study compared 3 periods when EOS management was based on (1) national recommended guidelines (baseline period [January 1, 2010, through November 31, 2012]), (2) multivariable estimates of sepsis risk at birth (learning period [December 1, 2012, through June 30, 2014]), and (3) the multivariable risk estimate combined with the infant's clinical condition in the first 24 hours after birth (EOS calculator period [July 1, 2014, through December 31, 2015]). The primary outcome was antibiotic administration in the first 24 hours. Secondary outcomes included blood culture use, antibiotic administration between 24 and 72 hours, clinical outcomes, and readmissions for EOS. The study cohort included 204 485 infants born at 35 weeks' gestation or later: 95 343 in the baseline period (mean [SD] age, 39.4 [1.3] weeks; 46 651 male [51.0%]; 37 007 white, non-Hispanic [38.8%]), 52 881 in the learning period (mean [SD] age, 39.3 [1.3] weeks; 27 067 male [51.2%]; 20 175 white, non-Hispanic [38.2%]), and 56 261 in the EOS calculator period (mean [SD] age, 39.4 [1.3] weeks; 28 575 male [50.8%]; 20 484 white, non-Hispanic [36.4%]). In a comparison of the baseline period with the EOS calculator period, blood culture use decreased from 14.5% to 4.9% (adjusted difference, -7.7%; 95% CI, -13.1% to -2.4%). Empirical antibiotic administration in the first 24 hours decreased from 5.0% to 2.6% (adjusted difference, -1.8; 95% CI, -2.4% to -1.3%). No increase in antibiotic use occurred between 24 and 72 hours after birth; use decreased from 0.5% to 0.4% (adjusted difference, 0.0%; 95% CI, -0.1% to 0.2%). The incidence of culture-confirmed EOS was similar during the 3 periods (0.03% in the baseline period, 0.03% in the learning period, and 0.02% in the EOS calculator period). Readmissions for EOS (within 7 days of birth) were rare in all periods (5.2 per 100 000 births in the baseline period, 1.9 per 100 000 births in the learning period, and 5.3 per 100 000 births in the EOS calculator period) and did not differ statistically (P = .70). Incidence of adverse clinical outcomes, including need for inotropes, mechanical ventilation, meningitis, and death, was unchanged after introduction of the EOS calculator. Clinical care algorithms based on individual infant estimates of EOS risk derived from a multivariable risk prediction model reduced the proportion of newborns undergoing laboratory testing and receiving empirical antibiotic treatment without apparent adverse effects.

Stress-Induced Hyperglycemia After Spontaneous Subarachnoid Hemorrhage and Its Role in Predicting Cerebrospinal Fluid Diversion.

Stress-induced hyperglycemia (SIH) after acute cerebrovascular disease is common and is associated with adverse clinical outcomes. The incidence of SIH after spontaneous subarachnoid hemorrhage (SAH) and its role in shunt placement have not been systematically investigated. The present study is designed to investigate the incidence of SIH after spontaneous SAH and its determinants. The role of SIH and premorbid hyperglycemia (using glycated hemoglobin [HbA1c]) in predicting external ventricular drainage (EVD) and ventriculoperitoneal shunt (VPS) placement is also investigated. This study defined SIH using the glycemic gap (GG) and admission glucose:HbA1c ratio. The receiver operating characteristic curve determined threshold values for GG and the ratio that best predicted incidence of adverse clinical outcomes, including in-hospital mortality. We defined SIH using thresholds of 26.7 mg/dL for GG and 26 mg/dL for admission glucose:HbA1c ratio. The incidence of SIH was higher in patients with aneurysmal SAH (aSAH) (99/200 [49.5%]) than in those with nonaneurysmal SAH (16/50 [32.0%]; P= 0.03). Among 200 patients with aSAH, diabetics had higher mortality than nondiabetics (10/24 [41.7%] vs. 39/137 [21.2%]; P= 0.045). SIH among nonhydrocephalic aSAH was more likely to have EVD placed than those without (42/64 [65.6%] vs. 38/79 [48.1%]; P= 0.043). Among 143 patients with aSAH without hydrocephalus, EVD was placed more often in those with HbA1c level ≥6.4% (15/19 [78.9%] vs. 65/124 [52.4%]; P=0.045). Neither SIH nor HbA1c level could predict VPS placement among aSAH survivors. SIH is common after aSAH. In nonhydrocephalic aSAH, both SIH and premorbid uncontrolled hyperglycemia determine EVD but not VPS placement.

Correlation of cardiac troponin I levels with infective endocarditis & its adverse clinical outcomes

BackgroundTo study the association of increased cardiac troponin I levels in infective endocarditis (IE) with its adverse clinical outcomes including in-hospital mortality, perivalvular invasive infection and central nervous system events. MethodsA prospective cohort study of 26 patients comprising of 19 males and 7 females with an average age of 28years diagnosed with IE using Modified Duke Criteria were taken. A blood sample was drawn from each patient and all samples were analyzed for quantitative estimation of troponin I using ELISA technique. A cardiac troponin I level >1.0ng/ml was considered increased. All data was analyzed by independent- samples t test using SPSS Version 16.0. ResultsAll 26 patients had vegetations diagnosed on echocardiography. Of the 26 patients, 9 (35%) had elevated cardiac troponin I levels and 17 patients (65%) had normal cardiac troponin I levels. Of the 9 patients who had elevated cardiac troponin I levels, 7 (77.78%) had adverse clinical outcomes, the level of statistical significance being p value<0.0002. Of the 17 patients with normal cardiac troponin I levels, only 1 (5.88%) had adverse clinical outcome, the level of statistical significance being p value<0.0001. ConclusionPatients with IE and increased cardiac troponin I levels have worse prognosis with increased incidence of adverse clinical outcomes than those with IE and normal cardiac troponin I levels reflecting potential of cardiac troponin I as a prognostic marker in IE.

Implementation of Clinical Decision Support Rules to Reduce Repeat Measurement of Serum Ionized Calcium, Serum Magnesium, and N-Terminal Pro-B-Type Natriuretic Peptide in Intensive Care Unit Inpatients.

We assessed the impact of clinical decision support (CDS) rules within the electronic health record for ionized calcium (iCa), serum magnesium (Mg), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) in intensive care unit (ICU) inpatients at a large academic center. A repeat order for measurement of iCa or Mg placed within 24 (iCa) or 48 (Mg) h of a previously nonactionable result, or additional orders for NT-proBNP beyond 1 within a single hospitalization, triggered a CDS pop-up alert showing the prior result and offering the opportunity to cancel the order or to place the order after entering an indication for repeat testing. The number of tests performed for each of these analytes and incidence of adverse clinical outcomes potentially associated with hypocalcemia or hypomagnesemia were compared between the 90-day period before CDS implementation and two 90-day periods immediately following. iCa test volumes decreased by 48%, Mg by 39%, and NT-proBNP by 28% in the 90-day period immediately following implementation and remained decreased by 54%, 49%, and 22%, respectively, during the following 90-day period (all P values <0.0002). Adverse clinical outcomes potentially associated with hypocalcemia or hypomagnesemia did not increase (all P-values >0.17). Implementation of CDS dramatically decreased repeat testing of iCa, Mg, and NT-proBNP without adversely impacting clinical outcomes in the ICU. Expansion of the rules from the ICU units to include the entire hospitalized patient population and expansion to additional analytes is expected to lead to further reductions in testing.

Thrombolysis for acute intermediate-risk pulmonary embolism: A meta-analysis

BackgroundThe use of thrombolytic therapy in patients with intermediate-risk pulmonary embolism is controversial. To compare with anticoagulation alone, no analysis before has determined whether thrombolytic therapy is associated with improved survival or lower incidence of adverse clinical outcomes for intermediate-risk pulmonary embolism. ObjectiveThis meta-analysis was performed to assess mortality benefits, bleeding and recurrent pulmonary embolism risks associated with thrombolytic therapy compared with anticoagulation in patients with intermediate-risk pulmonary embolism. MethodsThe Web of Science, PubMed, Embase, EBSCO, and the Cochrane Library databases were searched for randomized clinical trials comparing thrombolytic therapy with anticoagulation in intermediate-risk pulmonary embolism patients (in which the mortality data were reported) from inception to August 5, 2014. Primary outcomes were all-cause mortality and major bleeding. Secondary outcomes were recurrent pulmonary embolism and minor bleeding. The pooled relative risk (RR), Mantel–Haenszel corresponding method and fixed-effect model were used to estimate the efficacy and safety of thrombolytic therapy with 95% confidence intervals. ResultsEight clinical randomized controlled trials involving 1755 patients with intermediate-risk pulmonary embolism were included. Patients treated with thrombolytics presented lower mortality than patients in the anticoagulation cohort (RR, 0.52; 95% CI, 0.28–0.97; 1.39% [12/866] vs. 2.92% [26/889]). Compared with anticoagulation, thrombolytic therapy was associated with a higher risk of major (RR, 3.35; 95% CI, 2.03–5.54; 7.80% [64/820] vs. 2.28% [19/834]) and minor (RR, 3.66; 95% CI, 2.77–4.84; 32.78% [197/601] vs. 8.94% [53/593]) bleeding. Furthermore, thrombolytic therapy was associated with a lower incidence of recurrent pulmonary embolism (RR, 0.33; 95% CI, 0.15–0.73; 0.73% [6/826] vs. 2.72% [23/846]). ConclusionCompared with anticoagulation, thrombolytic therapy in patients with intermediate-risk pulmonary embolism is associated with lower all-cause mortality and recurrent pulmonary embolism risk despite increased major and minor bleeding risks.

Introduction: Why is intrapartum foetal monitoring necessary – Impact on outcomes and interventions

Maintaining maternal oxygen supply is essential for foetal life, and labour constitutes an increased challenge to this. Good clinical judgement is required to evaluate the signs of reduced foetal oxygenation, to diagnose the underlying cause, to judge the reversibility of the condition and to determine the best timing for delivery. The main aim of intrapartum foetal monitoring is to identify foetuses that are being inadequately oxygenated, enabling appropriate action before the occurrence of injury. It is also to provide reassurance in cases of adequate foetal oxygenation, and thus to avoid unnecessary obstetric intervention. Poor foetal oxygenation is diagnosed by documenting metabolic acidosis in the umbilical cord immediately after birth or in the newborn circulation during the first minutes of life. However, most newborns recover quickly, and they do not develop relevant short- or long-term complications. Hypoxic-ischaemic encephalopathy is the short-term neurological dysfunction caused by inadequate intrapartum foetal oxygenation, and cerebral palsy of the spastic quadriplegic or dyskinetic types is the long-term neurological complication most commonly associated with it. Although there is insufficient evidence from randomised controlled trials to demonstrate that any form of intrapartum foetal monitoring reduces the incidence of adverse outcomes, reports from the clinical setting have documented a decrease in metabolic acidosis, hypoxic-ischaemic encephalopathy and intrapartum death over the last decades. It may be difficult to demonstrate the benefit of diagnostic techniques in complex environments such as the labour ward, but a reduction in the incidence of adverse clinical outcomes constitutes important evidence that intrapartum foetal monitoring makes a difference.

Prevalence and Clinical Implications of Newly Revealed, Asymptomatic Abnormal Ankle-Brachial Index in Patients With Significant Coronary Artery Disease

This study sought to evaluate the association between newly revealed abnormal ankle-brachial index (ABI) and clinical outcomes in patients with significant coronary artery stenosis. Little is known about the prevalence and clinical implications of ABI in patients with no claudication or previous history of peripheral artery disease who undergo diagnostic coronary angiography. Between January 1, 2006, and December 31, 2009, ABI was evaluated in 2,543 consecutive patients with no clinical history of claudication or peripheral artery disease who underwent diagnostic coronary angiography. Abnormal ABI was defined as ≤0.9 or ≥1.4. The primary endpoint was the composite of death, myocardial infarction, and stroke over 3 years. Of the 2,543 patients, 390 (15.3%) had abnormal ABI. Of the 2,424 patients with at least 1significant stenosis (≥50%) in a major epicardial coronary artery, 385 (15.9%) had abnormal ABI, including 348 (14.4%) with ABI ≤0.9 and 37 (1.5%) with ABI ≥1.4. During a median follow-up of 986days, the 3-year major adverse event rate was significantly higher in patients with abnormal than normal ABI (15.7% vs. 3.3%, p < 0.001). After multivariate analysis, abnormal ABI was identified as a predictor of primary endpoint (hazard ratio [HR]: 1.87; 95% confidence interval [CI]: 1.23 to 2.84; p=0.004). After adjustment by propensity-score matching, abnormal ABI could predict adverse clinical events in patients with established coronary artery disease (HR: 2.40; 95% CI: 1.41 to 4.10; p=0.001). The prevalence of newly revealed abnormal, asymptomatic ABI among patients who have significant CAD on coronary angiography was 15.9%. The presence of abnormal ABI was associated with a higher incidence of adverse clinical outcomes over 3 years.

Incidence and Characterization of Percutaneous Lead Damage in the Heartmate II Left Ventricular Assist Device

Purpose The incidence of percutaneous lead failure due to wear and traumatic fracture among patients supported with a Heartmate (HM) II left ventricular assist device (LVAD) has not been previously reported. Methods and Materials The study is a retrospective review of all HM II LVAD percutaneous driveline malfunctions reported to Thoratec Corporation. Categorization of wear and failure by location and severity was performed and the incidence of adverse clinical outcomes as well as the management of the dysfunctional leads were examined. Results Between 2004 and October 2012, 12,969 HM II pumps were implanted worldwide. The incidence of percutaneous lead malfunction was 1,418 events occurring in 1,198 pumps (9.2%) over a cumulative support period of 13,932 patient-years (maximum = 7.3 years). Reported lead damage was mostly in the externalized part of the cable (87.2%). Lead malfunction was managed with external reinforcement in 7.5% of the implanted pumps, while mortality or significant morbidity including pump exchange or urgent transplant, or more complex end-cable replacement occurred in 2.3%. Percutaneous lead malfunction not associated with adverse events was managed by clamshell reinforcement of the connector strain relief or by tape/silicone cable reinforcement. The cumulative incidence of internal lead failures has decreased with two lead design revisions: 1.6% in 2004 (original design) vs. 0.01% in 2010 (redesigned internal pump end bend relief). Conclusions The incidence of HM II percutaneous lead malfunction associated with serious adverse events is low and the majority of patients who experience lead damage have been successfully managed by external repairs. The incidence of both internal and external lead failures has diminished since 2004 with progressive iterations and improvements in lead design.

Editorial The time has come to move from coronary angiography to physiological assessment of coronary lesions

Editorial The time has come to move from coronary angiography to physiological assessment of coronary lesions

Clinical Characteristics, Mortality, Cardiac Hospitalization, and Ventricular Arrhythmias in Patients Undergoing CRT‐D Implantation: Results of the ACTION‐HF Study

The characteristics and outcomes of patients who undergo cardiac resynchronization therapy (CRT) device implantation in current clinical practice may differ from those of reference trial populations. Study objectives were to assess 2-year outcomes in a population implanted with a CRT plus defibrillator device in accordance with the standard of care and to evaluate any independent association between clinical variables and outcome. A total of 406 patients enrolled at 35 centers in Italy were followed up prospectively for 2 years. All patient management decisions were left to the treating physician's discretion, in accordance with clinical practice. ACTION-HF patients had a better baseline clinical status than patients enrolled in the COMPANION study: shorter HF history (1 vs 3.5 years, P < 0.01), less advanced NYHA functional class (III-IV: 73% vs 100%, P < 0.01), higher LVEF (26% vs 21%, P < 0.01), higher SBP (122 vs 112 mmHg, P < 0.01), and less diabetes (27% vs 41%, P < 0.01). This status was reflected in lower mortality (11.5% vs 26%) and a lower incidence of appropriate ICD shocks (12.1% vs 19.3%). AF history was an independent predictor of the combination of all-cause mortality and cardiac-cause hospitalization (HR: 3.31; P < 0.001). Recurrent or new atrial arrhythmias were independently associated with the development of ventricular arrhythmias (HR: 3.4; P < 0.001). This population appears clinically less compromised and had a lower incidence of adverse clinical outcomes than those of reference trials. However, we recorded a substantial burden of atrial arrhythmias, which was independently associated with a higher incidence of ventricular arrhythmias.

Cell-derived microparticles in stored blood products: innocent-bystanders or effective mediators of post-transfusion reactions?

Cell-derived microparticles in stored blood products: innocent-bystanders or effective mediators of post-transfusion reactions?

Prevalence, Determinants, and Clinical Significance of Cardiac Troponin‐I Elevation in Individuals Admitted for a Hypertensive Emergency

Hypertensive emergencies (HEs) are frequently accompanied with the release of cardiac troponin I (cTnI); however, determinants and clinical significance of cTnI elevation are largely unknown. A retrospective analysis was performed on patients (n = 567) with a diagnosis of HE admitted to two tertiary care centers that primarily serve an inner-city population. Data on demographics, clinical variables, and cTnI were collected through chart review. Using regression analyses, predictors of cTnI elevation were studied and the impact of cTnI on all-cause mortality (data obtained through the Social Security Death Index) was determined. cTnI elevation was observed in 186 (32.3%) admissions with a mean peak cTnI level of 4.06 ± 14.6 ng/mL. Predictors of cTnI were age, history of hypercholesterolemia, blood urea nitrogen level, pulmonary edema, and requirement for mechanical ventilation. During a mean follow-up period of 3.1 years, there were 211 deaths (37%). Neither the presence nor the extent of cTnI elevation was associated with mortality, while age, history of coronary artery disease, and blood urea nitrogen level were predictive of mortality. cTnI elevation commonly occurs in the setting of HEs. Despite a high incidence of adverse clinical outcomes, cTnI elevation was not an independent predictor of mortality in this population.

Long-term Safety of Testosterone and Growth Hormone Supplementation: A Retrospective Study of Metabolic, Cardiovascular, and Oncologic Outcomes

BackgroundClinical research into the effects of hormonal supplementation has tended to focus on beneficial changes in anthropometric measures. There are fewer data on long-term safety with extended hormonal supplementation.MethodsAs part of a retrospective database survey, clinical outcomes were tabulated among patients who received at least 1 year of testosterone and/or growth hormone (GH) supplementation. In patients who were treated for at least 2 years, changes in markers of glucose and lipid metabolism were analyzed with and without concomitant use of oral hypoglycemics and statins.ResultsIn 263 patients (mean age 56) treated for at least 2 years, the only statistically significant effect on markers of glucose metabolism was an increase in glycated hemoglobin (still within normal limits) in patients receiving GH alone or in combination with testosterone but without oral hypoglycemics; with or without hypoglycemics, insulin levels showed no significant change. The only significant effects on markers of lipid metabolism were decreases in total cholesterol and low-density lipoprotein (LDL) in patients receiving combined testosterone and GH without statins. Decreases in LDL were significant in both the statin and non-statin groups; decreases in triglycerides were significant only in the statin group. In 531 patients treated for at least 1 year (mean age 54), the overall incidence of adverse clinical outcomes (prostate disease, diabetes, cardiovascular disease, cancer) was 1.3%.ConclusionsIn this retrospective survey, extended testosterone and/or GH supplementation did not adversely affect metabolic markers or clinical outcomes.KeywordsSafety; Testosterone; Growth hormone; Supplementation

Great Ormond Street Hospital for Children Registry for Congenital Melanocytic Naevi: prospective study 1988-2007. Part 2-evaluation of treatments

The treatment of congenital melanocytic naevi (CMNs) has become controversial as better data on complications have been published. To determine the longer-term risks and benefits of surgery in treatment of CMNs. In this 19-year prospective study, 301 families completed yearly questionnaires about treatments and CMN changes. Forty per cent of CMNs were > 20 cm projected adult size (PAS) or multiple CMNs. Girls were more likely to have had surgical treatments. There were no significant effects of treatment on the incidence of adverse clinical outcomes, although the numbers for melanoma were small. The majority of untreated CMNs lightened spontaneously during the follow-up period. Surgical treatment and satellites at birth were independently significantly associated with reported darkening of the CMN over the follow-up period. However there was no absolute measurement of final colour. Surgical treatment was associated with decreasing hairiness of the CMN over the follow-up period. PAS was associated with increasing hairiness. Excision with tissue expanders and PAS were significantly associated with an increased incidence of new satellite lesions. A proportion of patients reported new pigmentation in previously unaffected skin at the edge of a treated area, the majority after complete excision. There was a high level of satisfaction with surgery in the < 20 cm group and in those with facial CMNs. This was significantly reduced with increasing PAS. There is no evidence here that surgery reduces the incidence of adverse clinical outcomes in childhood. The natural history of the majority of untreated CMNs is to lighten spontaneously, whereas some treatments may cause adverse effects.

Meta-Analysis of Published Reports on the Effect of Statin Treatment Before Percutaneous Coronary Intervention on Periprocedural Myonecrosis

Myonecrosis, manifested by an increase in cardiac markers, may occur in up to 50% of patients undergoing elective percutaneous coronary intervention (PCI). The degree of periprocedural myonecrosis, measured by the peak creatine kinase-MB fraction, has been associated with incidence of adverse clinical outcomes. Therefore, strategies to decrease myonecrosis may translate into a decrease in mortality. We evaluated the efficacy of statin pretreatment in decreasing the incidence of myonecrosis after PCI on the basis of results of published studies. A systematic search of the PubMed database from its inception to October 2006 and from the references of identified studies was performed. Only studies with concurrent control groups were included. Information on baseline characteristics of included patients and clinical outcomes was independently extracted by 2 investigators. A random effects model was used to pool odds ratios of the incidence of periprocedural myonecrosis in statin-treated patients versus controls. A total of 9 trials was included in the analysis, 2 randomized trials (n = 604) and 7 retrospective cohort studies (n = 4,751), which assessed the impact of statin pretreatment on periprocedural myonecrosis. During this period, 196 of 2,149 patients (9%) in the statin-treated group compared with 455 of 2,602 (17.5%) in the control group (odds ratio 0.45, 95% confidence interval 0.33 to 0.62, p <0.01) developed myonecrosis. In conclusion, based on existing evidence, routine pretreatment with statins may decrease the risk of postprocedure myonecrosis. Large randomized controlled trials addressing the dose, duration, and type of statin on periprocedural myonecrosis are necessary before recommending routine use of statins to prevent myonecrosis in the elective PCI setting.

Update on viral hepatitis: 2005

This review aims to provide a concise summary of relevant developments in the treatment and prevention of viral hepatitis based on publications between December 2004 and November 2005. Long-term therapy with lamivudine was shown to reduce the incidence of adverse clinical outcomes in patients with chronic hepatitis B. This benefit was, however, diminished in patients with viral breakthrough. Combination therapy (peginterferon or telbivudine plus lamivudine) decreased the risk of antiviral resistance but did not improve response compared with monotherapy. Entecavir and tenofovir were shown to be effective in suppressing lamivudine-resistant hepatitis B. A shorter duration of peginterferon-ribavirin treatment was shown to be feasible in genotype 2/3 hepatitis C patients. Relapsers to previous standard interferon-based therapy had higher sustained virological response rates than previous non-responders when retreated with peginterferon-ribavirin. Hepatitis C patients with advanced liver disease may achieve sustained virological response with peginterferon-ribavirin treatment, but the complication rate was high. New insights into the management of viral hepatitis have been gained over the past year. The problem of antiviral resistance in chronic hepatitis B is real and treatment options need to keep evolving. Advances have been made in hepatitis C treatment including patients with genotypes 2 or 3 infection and decompensated cirrhosis.